CE certification requirements – CE certification notified body
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA).
The CE marking is required for many products. It:
- – shows that the manufacturer has checked that these products meet CE certification requirements
- – is an indicator of a product’s compliance with EU legislation
- – allows the free movement of products within the European market
By placing the CE marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE certificate. Manufacturers in the European Union (EU) and abroad must meet CE certification requirements where applicable in order for their products to export to Europe. This also applies to products made in third countries which are sold in the EEA and Turkey.
Not all products must get the CE certificate. Only those product categories subject to specific directives that provide for the CE certification are required to be CE marked.
EU certification does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.
If you are a manufacturer it is your responsibility to:
- – carry out the conformity assessment
- – set up the technical file
- – issue the EC Declaration of Conformity (DoC)
- – place CE marking on a product
If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.
If you are importing a product that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.
Products that need EU certification
EU certification is mandatory, but only for those products which are covered by the scope of one or more of the New Approach Directives.
Even if your product is manufactured outside the EEA, you must ensure the product bears CE marking if your product comes under the scope of a directive requiring CE certification. Not all products sold in the EU need to bear CE marking.
CE standard applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:
- – active implantable medical devices
- – appliances burning gaseous fuels
- – cableway installations designed to carry persons
- – eco-design of energy related products
- – electromagnetic compatibility
- – equipment and protective systems intended for use in potentially explosive atmospheres
- – explosives for civil uses
- – hot-water boilers
- – household refrigerators and freezers
- – in vitro diagnostic medical devices
- – lifts
- – low voltage
- – machinery
- – measuring instruments
- – medical devices
- – noise emission in the environment
- – non-automatic weighing instruments
- – personal protective equipment
- – pressure equipment
- – pyrotechnics
- – radio and telecommunications terminal equipment
- – recreational craft
- – safety of toys
- – simple pressure vessels
The CE standard is not required for items, for example:
- – chemicals
- – pharmaceuticals
- – cosmetics and foodstuffs
How to place a CE marking on a product
Before you place a CE marking on a product, you need to establish which EU New Approach Directives apply to your product. You must not attach a CE marking to a product outside the scope of the directives.
The process you follow depends on the directives that apply to your product.
Identify the directive(s) and harmonised standards applicable to the product
There are more than 20 directives setting out the product categories requiring CE certification. The essential requirements that products have to fulfil, for example safety, are created at EU level and are set out in general terms in these directives. Harmonised European standards are issued with reference to the applied directives and express the essential safety requirements in detailed technical terms.
Check the product-specific requirements
Every Directive has a number of ‘essential requirements’ that the product has to meet before being placed on the market. It is up to you to ensure that your product complies with the essential requirements of the relevant EU legislation. The use of harmonised European standards remains voluntary. You may decide to choose other ways to fulfil these essential requirements. If you don’t follow the safety requirements of an EU standard as it is written you will need to show that your product is as safe, by presenting the relevant documentation.
Identify whether an independent conformity assessment is required from a CE certification notified body
Although the process is always a self-declaration process,there are various ‘attestation routes’ to conformity depending on the Directive and classification of the product. Some products (such as invasive medical devices, or fire alarm and extinguisher systems) may, to some extent, have a mandatory requirement for the involvement of an authorised third party or “notified body”. The CE certification notified bodies carries out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required.
Test the product and check its conformity
If you manufacture a product it is your responsibility to test the product and check its conformity to the EU legislation (conformity assessment procedure). One part of the procedure is, as a general rule, a risk assessment. By applying the relevant harmonised EU standards, you will be able to fulfil the essential legislative requirements of the directives.
Compile the required technical documentation
If you manufacture a product you need to establish the technical documentation to ensure conformity to all European requirements and directives. You must be able to present the technical documentation and EC DoC to the relevant national authorities, if requested.
Placing the CE marking on your product and EC Declaration of Conformity
The CE marking must be placed on the product by the manufacturer, or by his authorised representative within the EEA or Turkey. It must be placed according to its legal format to the product or its data plate. It must be visible, legible and impossible to remove. If a CE certification notified body was involved in the production control phase, its identification number must also be displayed. It is the manufacturer’s responsibility to draw up and sign an ‘EC DoC’ proving that the product meets the requirements. That’s it, your CE-marked product is ready for the market.
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